Kornimate/medical-research-clean huggingface dataset:
phase 3 papulopustular rosacea study

Conditions: Papulopustular Rosacea (PPR)

Summary: the purpose of this study is to demonstrate that cd5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with papulopustular rosacea (ppr) and continues to be safe up to 12 months.


Eligibility criteria:
inclusion criteria: 1. the subject has papulopustular rosacea with an investigator global assessment (iga) score rated 3 (moderate) or 4 (severe), 2. the subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face. exclusion criteria: 1. the subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne, 2. the subject has rosacea with more than two nodules on the face.
remote assessment of outpatient with severe acute respiratory syndrome (sars-cov-2)

Conditions: SARS-CoV2 Infection

Summary: outpatient management of patients with a milder form of covid may be associated to an unfavorable initial or deferred course in relation to the pathology.. outpatients represent the bulk of patients with covid-19. to know their evolution, their secondary complications and identifying a profile of "at risk" patients is essential for the prevention and care of future non-hospitalized patients, in an epidemic context still active. this study could make it possible to redefine the follow-up of outpatients. the study consists of a simple questionnaire and possibly a teleconsultation.


Eligibility criteria:
inclusion criteria: * patients with a pcr (polymerase chain reaction assay ) positive for sars-cov-2 between the start of the pandemic and may 11, 2020 * outpatient care * inclusion 24 months from the date of diagnosis of sars-cov-2 (± 6 months) exclusion criteria: * patients in ehpad (accommodation facilities for dependent elderly people), home, retirement home, center for disabled people * patients under protective measure, curators or guardianship * patients with a pathology or condition that does not allow them to express their wishes * patients hospitalized when performing pcr or within 10 days with sars-cov-2
intraoperative and postoperative analgesia for laparoscopic surgery.

Conditions: Analgesia

Summary: main hypothesis: laparoscopic surgery is very painful to patient during and after surgery. we would like to compare different analgesic methods.


Eligibility criteria:
inclusion criteria: * laparoscopic (general) surgery * age\>18 * asa\<4 * morning surgery exclusion criteria: * patient refusal * contra-indication for treatment

Keywords: laparoscopic surgery (general surgery).
evaluation of the risk associated with impulsivity and other neuropsychological factors on suicidal relapse within hospital emergencies

Conditions: Suicide Attempt

Summary: suicidal behavior (sb) is a major public health problem in france, with over 10,000 suicides (6th in the eu28) and 220,000 suicide attempts (sa) per year. these data seem underestimated by 20%. a large percentage of men (6%) and women (9%) in france made at least one lifetime sa. in addition, sbs are common among young people and are the second leading cause of death among 15-44 year-olds. the interaction of multiple factors in sb complicates the creation of predictive models. these are currently imprecise and prevent the development of consensual recommendations for the management of suicidal patients. most suicide attempters are evaluated in the emergency room where it is imperative to identify people with a high risk of relapse. risk assessment is generally based on the experience of the practitioner who uses psychometric scales as support for clinical decisions. this assessment could be improved and supplemented by other sources of information. thus, we aim to develop a short and specific tool that combines: 1. neurocognitive measures carried out using computer software on domains strongly associated with sb: impulsivity, affective dysregulation, alterations in decision-making (risky choices), selective attention and verbal fluency. 2. clinical and psychological assessment including the most predictive items of future sa: life events (environment) and personality traits (vulnerability). suicide attempters will be assessed for sb and suicidal ideation in the emergency department. these measures will be repeated during a 12-month follow-up. we will use the data obtained to provide a more accurate measure of risk.

over 65 months, 5 emergency departments (montpellier, nimes, uzès, nice, marseille) will recruit a total of 650 patients who attempted suicide. * first visit: clinical and neuropsychological assessment * second and third visits at 6 and 12 months: assessment of sbs and suicidal relapse, clinical and neuropsychological assessment.

Eligibility criteria:
inclusion criteria: * being at least 18 years old * have committed a suicide attempt within 7 days prior to inclusion * receive minimal treatment (assessed by the clinician) * sign the informed consent * be able to understand the nature, the aims and the methodology of the study exclusion criteria: * patient with an actual or past history of psychotic disorder * patient not affiliated to a french social security system. * patient deprived of liberty (judicial or administrative decision) * patient aged 65 years or older with an mmse score \<24 at baseline. * patient in exclusion period after participation in another project * patient who has already achieved 4500€ of annual research allowances

Keywords: suicidal behavior suicide attempt emergency department psychometrics neuropsychological tests suicidal ideation
incidence of white spot lesions around ceramic brackets compared with metal brackets

Conditions: White Spot Lesion of Tooth

Summary: the main objective of this study was to investigate the relation between ceramic brackets and the development of white spot lesions (wsls) compared to that associated with conventional metal brackets.

objectives : the main objective of this study was to investigate the relation between ceramic brackets and the development of wsl compared to that associated with conventional metal brackets. study design: randomized 2-parallel arm clinical trial. materials and methods: quantitative light induced fluorescence (qlf) images were taken for the two randomly allocated groups (ceramic group, n=26; metal group, n=25) of patients at t0: before the start of treatment; t1: after 2 months and t2: at 4 months after treatment). the qlf images were analyzed; primary outcome measures: the lesion area (pixels) and mean amount of fluorescence loss (∆f)% and the number of newly developed lesions. secondary outcome: maximum fluorescence loss (∆f-max)% and plaque surface area (∆r 30)%. means and standard deviations for all the measured parameters at t0, t1 and t2 were calculated. split plot analysis of variance (spanova) test was used to determine the changes within each group at the different time intervals, and between the two groups. chi square was used to compare between the two groups regarding the number of new lesions during the treatment. p value was set at 0.05 level.

Eligibility criteria:
inclusion criteria: * healthy subjects seeking orthodontic treatment with mild-to-moderate crowding (not exceeding 5 mm) * no previous orthodontic treatment * optimum oral hygiene * maximum of 3 restored teeth * absence of defective enamel formation in the form of hypocalcification or hypoplasia. exclusion criteria: * subjects with poor oral hygiene * defective enamel * patients with syndromes and oro-facial anomalies or salivary glands diseases
macronutrient relations and weight loss in obese subjects

Conditions: Obesity

Summary: the burden of overweight and obesity has dramatically increased during the last decades. high carbohydrate intake, particularly refined carbohydrates, probably increase the risk of obesity, type 2 diabetes, and metabolic syndrome. there is evidence that energy-restricted low-carbohydrate diets show greater weight loss and better improvement of cardiovascular risk markers compared to energy-restricted low-fat diets. beside macronutrient relations, efficacy of weight loss programs depends on care and control. the investigators aim to investigate whether or not a carbohydrate-restricted telemedically guided weight loss program results in a more pronounced weight loss and influences metabolic risk markers more beneficial than a fat-restricted diet.

see brief summary.

Eligibility criteria:
inclusion criteria: * age 18-70 years * body mass index \> 27 kg/m2 exclusion criteria: * history of cardiovascular symptomatology * cholelithiasis * urolithiasis * insulin dependent diabetes * pacemaker implantation * pregnancy * lactation * vegetarianism

Keywords: weight reduction low-carbohydrate body fat telemedicine cardiovascular risk markers
chronic effects of the use of instep weights on specific capacities in soccer players

Conditions: Soccer; Physical Stress; Physical Performance

Summary: the main goal of this randomized controlled trial (rct) is to evaluate the chronic effects of using instep weights on technical, physical (conditional), and perceptual parameters in amateur male soccer players. the secondary objective will be to propose a training methodology using instep weights to enhance athletic performance. the following hypotheses are formulated based on the objectives outlined previously. hypothesis 1: the use of instep weights will enhance performance in ball striking speed, change of direction ability, and repeated sprint capacity. hypothesis 2: the use of instep weights will negatively affect performance in ball striking accuracy and ball control. hypothesis 3: the use of instep weights will not produce adverse effects on perceived exertion, groin pain or reduce maximal adductor, quadriceps and hamstring muscle contraction values.

a rct will be performed and players will be randomly assigned in one of the two groups (experimental or control). players will attend their regular training sessions and the protocol will be divided into two phases: * phase 1: familiarization on the recruitment day, players will be briefed on the study procedures, followed by the reading and signing of informed consent forms. familiarization with the study procedures will take place over the two weeks prior to the intervention phase. during this period, participants will practice all testing protocols once a week and will wear 100-gram instep weights in different training sessions. * phase 2: intervention during the intervention phase, all players who meet the inclusion and exclusion criteria will be recruited and will be randomly allocated into an intervention group (experimental) or a non-intervention group (control group). randomization will be conducted by an external researcher using blocked randomization via a web-based tool (urbinak, 1997). both groups will undergo distinct interventions over an 8-week period. the study will be conducted during the competitive season on artificial turf field under consistent environmental conditions. players will wear soccer boots for all testing procedures. testing will occur at three time points: * pre-intervention: first day of week 1 to collect baseline data. * mid-intervention: first day of week 5. * post-intervention: first day of week 9.

Eligibility criteria:
inclusion criteria: * amateur young male soccer player (under federation regulation) * minimum three years of experience playing soccer * train 3 days/week and 5 hours/week (minimum) exclusion criteria: * injured players * goalkeepers * players unable to perform at their best * players that will miss more than two training sessions * players under medication or using performance enhancement supplements * players under 16 years old

Keywords: performance accuracy agility soccer
inflammation in type 2 myocardial infarction

Conditions: Myocardial Infarction; Inflammation; Critical Illness

Summary: type 2 myocardial infarction (mi) is defined as myocardial necrosis that results from an imbalance of myocardial oxygen supply and demand. although type 2 mi is highly prevalent in patients with critical illness and strongly associated with mortality, the pathophysiology remains poorly understood. inflammation is central to the development of atherosclerosis, plaque rupture, and other subtypes of mi, but the role of inflammation in type 2 mi and myocardial necrosis has not been defined. the investigators aim to to delineate the mechanistic role of inflammation in myocardial necrosis and type 2 mi complicating critical medical illness.


Eligibility criteria:
inclusion criteria: * ≥21 years of age * admitted to the medical intensive or coronary care units * sepsis or respiratory failure * clinically indicated troponin measurement within 24 hours of icu admission exclusion criteria: * unstable angina or type 1 mi * percutaneous or surgical coronary revascularization within 7 days * heart failure exacerbation * primary valvular disorder * aortic dissection * infiltrative heart disease or hypertrophic cardiomyopathy * myocarditis * pulmonary embolism * electrocardiogram with \>1mm st segment elevation in two consecutive leads * serum cardiac troponin \>99th percentile url but no clear rise or fall pattern * history of chronic inflammatory disease * use of therapeutic-dose anticoagulants / antiplatelet agents other than aspirin * pregnant or incarcerated * enrolled in a competing study

Keywords: myocardial infarction inflammation critical illness necrosis sepsis respiratory insufficiency myocardial ischemia cardiovascular diseases heart diseases vascular diseases
trial of bibf1120 (nintedanib) in patients with recurrent or metastatic salivary gland cancer of the head and neck

Conditions: Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck

Summary: recently, sorafenib which can target vegfr and pdgfr demonstrated 13-16% of response rate in patients with recurrent/metastatic salivary gland cancers, suggesting that vegfr and pdgfr might be important role in salivary gland cancers. accordingly, several trials with various anti-angiogenic molecular targeted agents such as dasatinib, dovitinib, or sunitinib in salivary gland cancer are ongoing. nintedanib (bibf1120) is a potent small molecule triple receptor tyrosine kinase inhibitor (pdgfr/ fgfr1-2 and vegfr1-3). vegfr-2 is considered to be the crucial receptor involved in initiation of the formation as well as the maintenance of tumor vasculature. in vitro, the target receptors are all inhibited by nintedanib in low nanomolar concentrations. in in vivo nude mouse models, nintedanib showed good anti-tumor efficacy at doses of 50-100mg/kg, leading to a substantial delay of tumor growth or even complete tumor stasis in xenografts of a broad range of differing human tumors. based on this background, in this study, the investigators would like to conduct a phase ii study of nintedanib (bibf 1120) in patients with recurrent or metastatic salivary gland cancer of the head and neck to evaluate efficacy and safety.


Eligibility criteria:
inclusion criteria: * histologically proven salivary gland cancer of the head and neck (according to who classification, mucoepidermoid cancer, adenoid cystic carcinoma, or adenocarcinoma/salivary duct cancer are eligible) * recurrent or metastatic salivary gland cancer of the head and neck patients who failed one line of systemic chemotherapy * age ≥ 18 years * at least one measurable tumor lesion according to recist 1.1 * ecog performance status 0-2 * adequate hematologic function (absolute neutrophil count \> 1,500/m/, platelets \> 100,000/ml, haemoglobin \> 9.0 g/dl), hepatic function (alanine transaminase/aspartate transaminase \ 45 ml/min) * written informed consent exclusion criteria: * uncontrolled systemic illness such as dm, chf, unstable angina, hypertension, history or myocardial infarction in the 12 months prior to the start of the treatment, or arrhythmia * hemorrhagic or thromboembolic events in the past 6 months * major injuries in the 10 days prior to start of the study * patients with post-obstructive pneumonia or uncontrolled serious infection * pregnant or nursing women * uncontrolled symptomatic brain metastasis * prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, and well treated thyroid cancer
remote ischemic conditioning for parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose is to evaluate feasibility and efficacy of remote ischemic conditioning(ric) as adjuvant therapy for parkinson's disease(pd). sixty patients will be randomized into 2groups: ric group receiving remote ischemic conditioning except conventional therapy（n=30）and control group with conventional therapy (n=30).

remote ischaemic conditioning (ric) is a procedure whereby ischaemia is induced to a limb for short periods of time by inflating pressure cuffs around arms to above systolic pressures (mmhg). this procedure induce neurohormonal, systemic or vascular changes in the body. such changes often result in improved collateralisation of blood supply to various areas of the body, as well as improved efficiencies of cellular metabolism. ric has been shown to improve outcomes in patients with heart attacks, strokes, but is not investigated for pd. we argue that ric may exert neuroprotective effect on pd due to its multiple mechanisms. the aim of the study is to evaluate the impact of ric on long term outcomes in patients with pd.

Eligibility criteria:
inclusion criteria: * age between 40 - 70 years; * diagnosed with idiopathic pd; * a rating of 1-3 on the hoehn and yahr scale; * on optimized dopaminergic therapy for 4 weeks prior to enrollment; * be able to complete the research scale evaluation; * sign informed consent. exclusion criteria: * atypical parkinsonism or other significant brain conditions such as a stroke; * significant mental disease or psychosis; * history or presence of significant peripheral vascular disease in the upper limbs; * presence of skin ulceration to the arms; * deep brain stimulation ( dbs); * taking part in another clinical trial of an investigational medicinal product; * life expectancy less than 1 year due to severe medical disease; * other reasons that are unsuitable for the trial in the investigator's opinion.

Keywords: parkinson's disease remote ischaemic conditioning
single dose bronchodilatory study in asthma

Conditions: Asthma

Summary: study to evaluate the bronchodilator effects of zyflo cr in patients with chronic stable asthma.


Eligibility criteria:
inclusion criteria: * diagnosis of asthma for at least 5 years * fev1 of 50-85% predicted * reversible airway obstruction exclusion criteria: * pregnant/nursing females * liver function tests greater than upper limit of normal
short period incidence study of severe acute respiratory illness

Conditions: Severe Acute Respiratory Infection

Summary: this is a multi-centre, prospective, short period incidence observational study of patients in participating hospitals and intensive care units (icus) with sari. the study period will occur, in both northern and southern hemispheric winters. the study period will comprise a 5 to 7-day cohort study in which patients meeting a sari case-definition, who are newly admitted to the hospitals / icus at participating sites, will be included in the study. the study will be conducted in 20 to 40-hospital/ icu-based research networks globally. all clinical information and sample data will only be recorded if taken as part of the routine clinical practice at each site and only fully anonymised and de-identified data will be submitted centrally. the primary aim of this study is to establishing a research response capability for a future epidemic / pandemic through a global sari observational study. the secondary aim of this study is to investigate the descriptive epidemiology and microbiology profiles of patients with sari. the tertiary aim of this study is to assess the ethics, administrative, regulatory and logistic (earl) barriers to conducting pandemic research on a global level.

severe acute respiratory infection (sari) continues to be of major relevance to public health worldwide. in the last 10 years there have been multiple sari outbreaks around the world. the 2009 h1n1 pandemic was estimated to result in more than 200,000 respiratory deaths globally. the world health organization (who) defines sari as an acute respiratory infection of recent onset (within 10 days) requiring hospitalisation, manifested by fever (≥38oc) or a history of fever and cough. there is international consensus that it is important to undertake observational studies of patients with sari as an essential component of pandemic and epidemic research preparedness.

Eligibility criteria:
inclusion criteria: * a history of feverishness or measured fever of ≥ 38 deg c; * cough; * dyspnoea (shortness of breath) or tachypnoea. exclusion criteria: • no exclusion criteria

Keywords: severe acute respiratory infection
progression of sub-clinical atherosclerosis

Conditions: Atherosclerosis; Cardiovascular Diseases; Heart Diseases; Carotid Artery Diseases

Summary: to determine the rate of progression of sub-clinical cardiovascular disease as measured in carotid intimal medial thickness over a period of 8 to 10 years.

background: strong associations exist between cardiovascular events and increased carotid artery wall intima-media thickness (imt) as measured non-invasively by carotid ultrasound. carotid imt is accepted as a surrogate marker of sub-clinical cardiovascular disease.the study will determine the rate of progression of sub-clinical cardiovascular disease (change in imt) over a period of 8 to 10 years. design narrative: the study will determine the rate of progression of sub-clinical cardiovascular disease (change in intimal medial thickness {imt}) over a period of 8 to 10 years. imaging and imt measurements of approximately 2800 to 3000 members of the framingham offspring cohort having had baseline imt measurements at their 1995-98 clinic visit will be repeated in 2005-2007. the principal aims of the project are to study the primary hypotheses that: 1. interim exposure to traditional cardiovascular risk factors measured over 50 years is positively associated with the progression rate of carotid imt. 2. baseline carotid imt and cumulative exposure to cardiovascular risk factors 20 years before the baseline visit are a better predictor of progression of sub-clinical disease after 8 to 10 years than the interim exposure to risk factors. 3. novel risk factors such as c-reactive protein and homocysteine affect progression of carotid atherosclerosis more than traditional risk factors. this study will add a phenotypic marker of site-specific change in sub-clinical cardiovascular disease to the framingham study database. this complements ongoing research on the progression of sub-clinical cardiovascular disease and its associations with family history of premature cardiovascular events and genomic markers

Eligibility criteria:
no eligibility criteria